XLTEK EEG32U Amplifier User and Service Manual
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Table of Contents
Contact Information ...................................................................................................................................................... 1
Introduction ................................................................................................................................................................... 4
Device Description ..................................................................................................................................................... 4
Intended Use ............................................................................................................................................................. 4
Indications for Use ..................................................................................................................................................... 4
Intended User ............................................................................................................................................................ 5
Patient Target Group ................................................................................................................................................. 5
Residual Risks ............................................................................................................................................................. 5
Medical Conditions .................................................................................................................................................... 5
Clinical Benefit ........................................................................................................................................................... 5
Essential Performance ............................................................................................................................................... 5
Clinical Performance .................................................................................................................................................. 5
General and Network Security Measures .................................................................................................................. 6
General Security Policies ....................................................................................................................................... 6
Networked Environments ...................................................................................................................................... 6
Secure Access to Windows Systems ...................................................................................................................... 6
Data Confidentiality ............................................................................................................................................... 6
Data Protection ...................................................................................................................................................... 6
User Manual and eIFU ............................................................................................................................................... 6
Specifications: EEG32U Amplifier .................................................................................................................................. 7
EEG32U Amplifier Safety and Standards Conformity .................................................................................................... 9
Standards of Compliance and Normative References ............................................................................................... 9
Declaration of Compliance for IEC 60601-1-2 ......................................................................................................... 11
Declaration of Compliance for FCC .......................................................................................................................... 15
Warnings and Cautions ................................................................................................................................................ 16
Contraindications ..................................................................................................................................................... 16
General Warnings .................................................................................................................................................... 16
Electrical Warnings and Cautions ............................................................................................................................ 17
Patient Environment Warnings and Cautions.......................................................................................................... 18
Transportation Warnings ......................................................................................................................................... 19
Conducted Immunity Warnings ............................................................................................................................... 19
Procedures and Warnings............................................................................................................................................ 20
Electrostatic Discharge (ESD) Handling .................................................................................................................... 20
Conducted Immunity Procedures and Warnings ..................................................................................................... 21
Description of Symbols ................................................................................................................................................ 22
Product Images ............................................................................................................................................................ 30
EEG32U Amplifier .................................................................................................................................................... 30
Unpacking .................................................................................................................................................................... 31
Setting Up .................................................................................................................................................................... 31
Placement of the Operator and Patient .............................................................................................................. 31
Beginning a study................................................................................................................................................. 31
Powering Down the System ................................................................................................................................. 31
Connecting to a Computer....................................................................................................................................... 32
Testing the EEG32U Amplifier ................................................................................................................................. 32
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